Efficacy and safety of increased dose and duration of oral Itraconazole therapy in recurrent tinea corporis et cruris – a comparative study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- 1.Mycological cure in group A,B and C.
研究概览
简要总结
BACKGROUND:Currently, dermatologists across India are inundated with cases of dermatophytosis presenting with unusual large lesions, ring within ring lesions, multiple site lesions (tinea cruris et corporis), and corticosteroid modified lesions, making diagnosis a difficult bet .In addition, chronicity of the disease has plagued the patients unlike any other dermatological condition in the country .The American Academy of Dermatology guidelines on the management of tinea cruris and corporis were published two decades ago. Also, the treatment recommendations in the standard textbooks of dermatology appear to have lost their relevance in the current clinical scenario . Thus, the management of dermatophytosis in India is in need of an evidence-based, experience-driven, practical approach from the experts in the field .The existing evidence is primarily based on observational cohort studies rather than randomized controlled trials (RCT). Properly designed RCTs are required to address these need gaps. There are published guidelines on tinea capitis and unguium . However, these are not applicable for the treatment of other dermatophytosis, like tinea corporis, cruris and pedis, in the current scenario in India.Failure to get a satisfactory clinical outcome with the Standard Dosage Regimens(5mg./kg./day,with maximum of 200mg./day) of Oral Itraconazole Therapy for 4weeks. compelled us to try out the Increased Dosage Regimen (10mg./kg./day,with maximum. of 400mg./day)for longer duration of treatment.
OBJECTIVES: To evaluate the efficacy and safety of increased dose and duration of itraconazole in recurrent tinea corporis and tinea cruris.
METHODS: A single centre hospital based three arm, pilot randomized open label trial is planned in accordance with the declaration of Helsinki protocols. All patients will be selected based on their eligibility criteria after obtaining written informed consent to participate in the study. The study will be conducted at the Department of Dermatology, Venereology & Leprology outpatient department of Kalinga Institute of Medical Sciences, Bhubaneswar. The study duration will be one year. All the eligible patients will be randomly allocated in to three groups.Group A patients will receive oral itraconazole 400mg per day for 4weeks, group B patients will receive itraconazole 400mg per day for 8weeks.Group C patients will receive itraconazole 400mg per day for 12 weeks duration. Clinical and mycological cure rates in the three groups will be evaluated. Relapse rate in the three groups will be assessed up to 12 weeks after treatment.Adverse drug reactions if any will be recorded and monitored.SAMPLE SIZE: Total 120 eligible patients will be divided in to three groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 12.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either gender with body weight ≥40 kg diagnosed with Tinea corporis & tinea cruris who are poor responders to the standard dosage regimen (100mg.
- •of oral Itraconazole therapy for 4 wks twice daily.)
- •Patients of Tinea corporis & tinea cruris with frequent relapses after taking standard dosage regimens of oral Itraconazole for more than 6 months.
- •Female Patients of reproductive age group willing to follow contraceptive procedures during the study period.
排除标准
- •Patient less than 12 years and more than 70 years of age/ less than 40 kg.
- •body weight.
- •Patient with any immunocompromised medical status viz.
- •Diabetes Mellitus, HIV Infection, Immunosuppressive therapy.
- •Patient suffering from any other illness like Congestive Cardiac failure and chronic kidney disease and patients with elevated liver enzymes (more than 2 times of upper limit of normal)
- •Patients taking drugs viz.
- •rifampicin, phenytion, digoxin, anticoagulants, terfenadine, diseases which are contraindicated with itraconazole as co-therapy.
- •Any Oral or Topical Antifungal Therapy within 1 month of before the start of treatment trial
- •Patients who are not capable enough to bear the cost of treatment & investigations ,not cooperative enough to come for follow up.
- •Pregnancy and Lactation.
结局指标
主要结局
1.Mycological cure in group A,B and C.
时间窗: every two weeks for 4 weeks , 8 weeks and 12 weeks
2.Clinical Cure: Improvement in Clinical Signs and Symptoms Investigator’s assessment to be rated on a 4-Point scale .Treatment Efficacy is measured by the Investigator using a 4-Point scale
时间窗: every two weeks for 4 weeks , 8 weeks and 12 weeks
3.Safety of Treatment- Any adverse drug reactions will be noted at each visit.
时间窗: every two weeks for 4 weeks , 8 weeks and 12 weeks
It will be assessed by recording Investigator’s &Patient’s assessment of tolerability.
时间窗: every two weeks for 4 weeks , 8 weeks and 12 weeks
次要结局
- Rate of relapse after completion of study period in each group.(twelve weeks)